Clinical Outcome After Implantation of Medicontur Liberty 677MTY, a Multifocal, Toric IOL

Cataract Clinical Trial

Official title:

Clinical Outcome After Implantation of Medicontur Multifocal, Toric Intraocular Lens Liberty 677MTY: Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04670237
• Other study ID #: MC_Liberty677MTY_HU_2019
• Status: Enrolling by invitation
• Start date: December 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate visual outcomes, patient satisfaction and YAG capsulotomy rate after implantation of a multifocal toric lens- Liberty 677MTY - manufactured by Medicontur Ltd. (Zsámbék, Hungary),

Description:

The purpose of this study is to evaluate visual outcomes, glass independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of multifocal diffractive apodized toric intraocular lens- Liberty 677MTY - diffractive-refractive apodized IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary).

The tested IOL model, Liberty 677MTY, has an overall length of 13 mm, an optic diameter of 6.0 mm without haptics angulations but with posterior vaulting. The refractive index of the optic material is 1.46 (at 23°C). The IOL is a single-piece-IOL, the optic and haptics are made from a hydrophilic acrylic co-polymer with integrated - covalently bound UV absorbent. The IOL is produced with yellow filter, covalently bound yellow chromophore. The toric component of Liberty 677MTY IOL is located on the posterior surface of the lens optic. The optic is marked with 2 marks. The marks are positioned exactly in middle between the two loops of haptic at the angulation at the flat axis of toric equivalent. The Liberty 677MTY is available with cylinder powers of 1.0 diopter (D) to 6.0 D. The IOL is designed with sharp edge following 360º to prevent migration of the lens epithelial cells , thereby to prevent PCO formation.

The trifocality of the lens is provided by the EPS technology recently developed by Medicontur uses an elevated phase shift on the central diffractive part of the lens in order to cause constructive interference between the 0th (far) and 1st diffractive (near) order, thus creating a 3rd (intermediate) focal point.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• astigmatism less than 1 dpt

• irregural astigmatism

• diabetic retinopathy

• iris neovascularisation

• serious intraoperative complications

• congenital eye abnormality

• glaucoma

• pseudoexfoliation syndrom

• amblyopia

• uveitis

• long-term anti-inflammatory treatment

• AMD (advanced AMD)

• retinal detachment

• prior ocular surgery in personal medical history

• corneal diseases

• severe retinal diseases (dystrophy, degeneration)

• severe myopia (if required IOL power is lower than 10 D)

• inadequate visualization of the fundus on preoperative examination

• patients deemed by the clinical investigator because of any systemic disease.

• eye trauma in medical history intraoperative exclusions:

• tear in capsulorhexis

• zonular dehiscence

• posterior capsular rupture

• vitreous loss and other unexpected surgical complication

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Liberty677MTY Multifocal Toric IOL
multifocal, toric intraocular lens (IOL)

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Ophthalmology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens on day one, seven, month one, three and one year postoperatively	1 year
Secondary	Visual outcome	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart at month one, three and one year postoperatively	1 year
Secondary	Contrast sensitivity	Contrast sensitivity will be assessed by using the CSV-1000 method in photopic and mesopic light condition three month and one year after implantation	1 year
Secondary	YAG capsulatomy	The rate of YAG capsulatomy will be assessed during the one year follow-up	1 year
Secondary	Patient satisfaction	Patient satisfaction will be assessed by using the VFQ-25 questionnaire three month and one year postoperatively	1 year